NCT05093738

Brief Summary

Children are the most vulnerable group to be affected by war. The long-term effects of exposure to conflict on children's mental, physical and cognitive development have been documented in the context of war and refugee camps. It has been shown that children who experience war have difficulties in cognitive skills such as attention, learning new information, memory and executive functions. Cognitive skills can ensure a child's school readiness and successful participation in school. Therefore, assessment of children's cognitive performance components can provide a more fundamental understanding of their skills and barriers in school performance. Although there are studies to develop occupational therapy programs in schools for refugee children in the world. No intervention studies specifically aimed at cognitive rehabilitation were found. Therefore, it was aimed to perform cognitive rehabilitation for refugee children and to examine the effects of this on cognitive skills, academic performance and quality of life. The hypotheses on which there is no effect of school-based cognitive rehabilitation approach on cognitive skills, academic performance and quality of life in refugees. The population of the study will be 34 children (17 studies, 17 controls) between the ages of 12 and 16 who scored 12 points or higher on the Post-Traumatic Stress Scale for Children in Istanbul Secondary School and scored below 21 on the Montreal Cognitive Assessment Scale. Loewenstein Occupational Therapy Cognitive Assessment Scale to assess students' cognitive status; Reading Speed Test and Minnesota Writing Test to assess their academic performance; Pediatric Quality of Life Inventory will be used to assess their quality of life. Refugee children in the study (cognitive rehabilitation intervention) and control groups will be evaluated primarily with the help of these assessment scales, and the individuals in the study group will be given 2 sessions of intervention per week for 10 weeks, with an average of 1 hour per session. At the end of 10 weeks, the participants will be re-evaluated with the help of the same scales and the effectiveness of cognitive rehabilitation will be examined.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

September 28, 2021

Last Update Submit

October 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Loewenstein Occupational Therapy Cognitive Assessment Scale

    Loewenstein Occupational Therapy Cognitive Assessment battery is a cognitive screening test which is widely used in occupational health. The application takes 30-45 minutes. Loewenstein Occupational Therapy Cognitive Assessment Scale consists of a total of 26 subtests within 6 areas: Orientation (2 items); Visual Perception (4 items); Spatial Perception (3 items); Motor Praxis (3 items); Visuomotor Organization (7 items); and Thinking Operations (7 items). LOTCA score ranges from 26 to 115 points. Minimum score is 26. Maximum score is 115.

    10 weeks

Secondary Outcomes (2)

  • Evaluation of reading speed Minnesota Handwriting Test

    10 weeks

  • Quality of Life Scale for Children

    10 weeks

Study Arms (2)

Rehabilitation Group

EXPERIMENTAL

Refugee Children taking cognitive rehabilitation

Other: Cognitive Rehabilitation

Control Group

NO INTERVENTION

Refugee Children not taking cognitive rehabilitation

Interventions

In the content of the person-centered intervention program, attention, memory, orientation, praxis (motor planning) training; metacognition (metacognition) training; visual perception; There will be cognitive training for executive functions. The intervention will consist of play activities (games, computer-assisted games) for cognitive skills; The games will be applied in a way that suits the child from simple to complex. Visual perception applications (designing blocks, recognizing and sorting the shapes in the picture, matching opposite shapes etc.); attention practices, memory practices, strategy development, space-time orientation, motor planning, games and metacognitive strategies aimed at developing skills such as planning, organization, working memory, impulse control, time management and awareness, abstract thinking, cognitive flexibility will form our intervention program.

Rehabilitation Group

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Post-Traumatic Stress Reaction Index for Children score should be taken 12 points
  • Montreal Cognitive Assessment Scale score should be taken below 21 points
  • being between the ages of 12-16
  • having experienced war in their country
  • Participants must know Turkish well
  • Both the child and the parent must volunteer to participate in the study.

You may not qualify if:

  • Having a known neurological, developmental or learning disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This prospective studies that measure the effectiveness of a cognitive rehabilitation intervention. Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Participants are recruited and randomly assigned to either the intervention or the comparator group. It is important to ensure that at the time of recruitment there is no knowledge of which group the participant will be allocated to; this is known as concealment. It is examined whether there is any difference in the results of the study intervention and also the intervention and control group are compared.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 26, 2021

Study Start

October 25, 2021

Primary Completion

January 7, 2022

Study Completion

January 20, 2022

Last Updated

October 26, 2021

Record last verified: 2021-10